Water for Injection (WFI)

Water for parenteral preparations and for final rinsing of product-contact equipment in sterile manufacturing. It has a typical microbial action level of 10 CFU/100 mL, an endotoxin limit below 0.25 EU/mL, and must meet conductivity and TOC requirements. WFI is traditionally produced by distillation, though membrane-based methods are now accepted in many markets, and is usually stored and circulated hot at 65–80 °C.